Catalog Number

-

Brand Name

stay.safe®

Version/Model Number

050-95004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173593,K904806,K173593,K904806

Product Code

KDJ

Product Code Name

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Public Device Record Key

6d488598-e5cf-4341-ae57-5f7f305805ef

Public Version Date

July 23, 2018

Public Version Number

4

DI Record Publish Date

October 02, 2015

Package DI Number

10840861100788

Quantity per Package

100

Contains DI Package

00840861100781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-